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Criminal No. 15-10076-ADB



Through this motion, Defendants William Facteau and Patrick Fabian (Defendants) list
five categories of evidentiary objectionsthe first four of which were raised in their pre-trial
motions in liminethat have recurred with some regularity thus far during trial. 1 Defendants
respectfully request that the Court revisit these issues and issue rulings that rein in the
Governments most frequent transgressions. With the exception of the fifth category (repetitive
leading questions), Defendants propose that, going forward, in an effort to reduce the number of
sidebar conferences, defense counsel simply invoke the number assigned to each category when
asserting objections during trialby stating, for example, Objection, Ground 1. Defendants
also confirm that, as they have done to date, only one defense counsel need object to any given
question, with that objection deemed asserted on behalf of both Defendants.

For purposes of this pleading, and without waiving any of the other evidentiary issues
they have raised to date in their pleadings or at trial, Defendants list only those issues that have
occurred most frequently.

1. Adverse Events and Alleged Safety Issues (Dkts. 287, 291, 370)
Defendants renew their objection to the Governments repeated efforts to elicit testimony
and introduce evidence concerning alleged risks, adverse events, and other safety-related issues
concerning the Stratus, including but not limited to the alleged risks of the trocar, implantation,
wing detachments, migrations, and the like. Among other reasons,

Such evidence is not relevant to any count in the Indictment, which charges
adulteration and misbranding and limits its few safety-related allegations to offlabel uses of the Stratus (see Indictment 120); 2

The Government has laid no predicate that might make such evidence relevant,
either by proving the existence of specific misrepresentations concerning safety
that might give rise to a duty to disclose, or otherwise;

Even if the evidence were marginally relevant, its relevance is substantially

outweighed by its prejudicial impact; and

The Governments repeated efforts to make this trial a referendum on whether

Defendants placed a dangerous product into the stream of commerce constitute
not only a variance from the Indictment but also an improper attempt to inflame
the passions and prejudices of the jury.

Representative examples include the Governments repeated assertions in its opening

statement about the danger of implanting the Stratus with a super-sharp needle right next to
your eyes and separated from your brain by only a paper-thin barrier, Tr. 228:11-15, 229:1720; questions to Dr. Armstrong on both direct and re-direct eliciting testimony that described the
trocar as akin to a nail being inserted in a patients head between the eyes, Tr. 347:1-2, 3
49:1-4, 3151:21-152:2, 4101:3-15, and as something that might puncture the carotid
artery, 3152:3-10; questions to Mr. Steffen seeking to elicit testimony about the alleged risk of

Paragraph 120(c) alleges a failure to provide safety information with respect to the offlabel use of Stratus with Kenalog. Paragraph 120(e) alleges a failure to provide safety
information with respect to the off-label implantation of Stratus for longer than 14 days, which
the FDA (erroneously) believed may have contributed to two wing detachments during the
DELIVER clinical study.

piercing the carotid artery, Tr. 7119:4-120:22; questions to Mr. Convery about a Stratus
allegedly being lost in a patient, Tr. 9131:8-14, 9134:24-135:8; questions to Dr. Chong
about the type of surgery that would be needed to retrieve a detached wing, Tr. 8149:11-25; and
questions to numerous witnesses about the nitinol wings of the Stratus breaking off when in
the patient. E.g., Tr. 3169:2-7, Tr. 746:7-21, Tr. 8148:18-149:10.
For reasons known only to the Government, the prosecutors elected to bring criminal
charges in a purported off-label promotion case where: (a) patients benefitted from the alleged
off-label use (which use was, of course, completely legal); (b) no patient ever was harmed from
that use; and (c) the FDA never deemed it necessary to warn anyone about any potential risk of
harm. Having made that decision, the Government should not be permitted to raise the specter of
safety risks to try to frighten the jury into a factually and legally unjustifiable conviction.
2. Fraud by Omission (Dkt. 297)
Defendants renew their objection to the Governments repeated questions to both
Acclarent employees and physicians about purported facts that allegedly were not disclosed. The
Government has laid no foundation sufficient to establish a duty to disclose; its questions
presume facts that it has made no effortto dateto establish; and the end result is to interject
issues that are irrelevant, unfairly prejudicial, and can serve only to confuse and mislead the jury.
Representative examples include, but are not limited to, questions about whether sales
representatives mentionedor doctors were toldabout wing detachments, e.g., Tr. 634:1-6,
746:14-16, 8148:18-21, the FDAs alleged decision to stop the DELIVER study, Tr. 634:2335:4, 8150:2-5, the FDAs alleged denial of a drug indication, Tr. 7189:13-19; see also Tr. 2
33:11-23 (assertion in Governments opening statement that FDA said a very clear no to
selling the Stratus for drug delivery), information purportedly showing that Stratus with

Kenalog was ineffective or less effective than other treatments for ethmoid disease, Tr. 8
150:21-151:5, 9139:23-140:5, or the financial compensation paid to members of Acclarents
Scientific Advisory Board. Tr. 5131:23-25; see also 4111:9-19 (eliciting mere hypothesis that
if a physician were a large shareholder in Acclarent his study results might be biased).
Having chosen to bring a criminal case based on truthful speech, the Government cannot
attempt to transform that speech into falsehoods through the purported breach of duties to
disclose that the Government has failed to establish even existed.
3. Testimony Concerning a Witnesss Understanding of What Another Person Said
(Dkt. 302)
Defendants renew their objection to the Governments repeated questions asking
witnesses to convey their understanding of what another person said. Indeed, many of these
questions have asked witnesses to opine concerning their understanding of written statements
whose content is not only undisputed but also often projected for the jurors to read on the screen.
Such questions are irrelevant, usurp the jurys fact-finding function by telling the jury what result
to reach, and are cumulative and a waste of time.
Representative examples include questioning marketing director Oakes about her
understanding of how Stratus worked after she spoke with engineer Ketan Muni outside his
cubicle, Tr. 7169:1-19, showing her a document and questioning her about her understanding
as to whether the device [with saline] would work to facilitate an easier removal of the stent
after hearing Scientific Advisory Board members discuss use of the device with saline, Tr. 7
197:4-24; showing Dr. Armstrong a slide stating that Stratus may be left in the ethmoid
complex for up to 14 days and that the reservoir facilitates bathing, and then asking what he
would understand that to indicate could be done with saline? Tr. 377:10-78:1; showing Dr.
Armstrong an e-mail from regulatory employee Deb Cogan saying I would not include a control

arm in that study and then asking What was your understanding about why she didnt want you
to include a control arm? Tr. 3116:20-24; showing Ms. Vanderkarr an e-mail from Mr. Fabian
regarding Catalog Only procedure and asking What was your understanding of the message that
Mr. Fabian was sending with these comments? Tr. 5202:22-203:4; and showing Mr. Steffen a
presentation given by Mr. Convery and asking Mr. Steffen what he understood Mr. Convery to
be recommending. Tr. 789:12-98:15.
Absent a situation involving code wordswhich is not this casea witnesss professed
understanding of another persons statement is wholly irrelevant. The Governments
rejoinderthat the testimony is not being introduced for the truth but to establish state of
mindis unavailing. The witnesss state of mind is not relevant to any legitimate issue in this
case. 3 Instead, the Governments apparent objective is to have its witnesses choose sides and
usurp the jurys fact-finding function by effectively telling the jury that it should interpret
various statements consistent with the Governments theory of the case. Such testimony violates
the limits placed on lay opinion testimony by Fed. R. Evid. 701. Further, to the extent the
writings are by persons whom the Government has indicated it will call as witnesses, eliciting
testimony about it from recipients is cumulative and a waste of time in violation of Rules 403
and 611(a)(2). The Government should be limited to introducing evidence concerning the actual
text of what was said.

The Court previously has acknowledged this very point. See Tr. 7201:25-202:3 ([I]f
a doctor says, This is what I said in the meeting and Facteau heard it, thats different than [a
witness such as Ms. Oakes] saying, This is what he said and what I understood it to mean.). It
also acknowledged that admitting such statements for other than the truth of the matter would
almost certainly confuse the jury and be not fair. Tr. 7203:1-15.

4. Hearsay Not Within Any Exception (Dkt. 285)

Defendants object to the Governments repeated efforts to elicit testimony from witnesses
concerning out-of-court statements made by third parties. Prior to trial, the Government
produced a lengthy list of alleged unindicted co-conspirators, thereby suggesting that it intended
to invoke the co-conspirator exception to the rule against hearsay. Fed. R. Evid. 801(d)(2)(E).
At a pre-trial hearing scheduled to address the governments ability to make the threshold
showings required under Petrozziello, the Government changed courseasserting that it would
not be seeking to introduce many alleged co-conspirator statements after all, and that such
statements would not be introduced for the truth of the matters asserted.
As trial has progressed, it has become increasingly clear that the Government intends to
put on its case through proxies. Rather than call as witnesses the individuals who purportedly
made or authored the statements at issuewhich would provide defense counsel with an
opportunity to cross-examine the declarantsthe Government instead has opted to introduce the
evidence through third parties, on the theory that it is not being introduced for the truth of the
matter asserted but rather to show the witnesss state of mind. Further, on numerous occasions,
the Government has elicited hearsay with no indication as to who the declarant even was.
Instead, the Government has elicited testimonyoften in the passive voicethat out-of-court
statements were made by (or to) unnamed managers or management, or, even more vaguely,
that variously characterized sales practices were encouraged by unidentified others.
Representative examples include the Government asking Dr. Armstrong what an
unnamed sales representative told [him] the device should be used for prior to the Sinus
Forum, Tr. 340:24-41:17; eliciting from Dr. Armstrong what other physicians stated or
believed, and what data did or did not show, regarding Stratuss safety and effectiveness, Tr. 3

52:6-59:12; and questioning Ms. Oakes about what engineering and medical experts stated about
saline elution. Tr. 7197:19-206:20; see also, e.g., Tr. 350:9-18 (we were clearly encouraged
or it was very clearly stated that the expectation was that we would not put saline in this); 5
153:16-154:2 (statements by unidentified managers); 7126:13-16 (encouragement by
unnamed management); accord 7128:15-20; 935:14-36:6.
The Government plainly intends for the jury to believe the truth of the matters asserted;
the witnesss state of mind is wholly irrelevant; and the Governments repeated invocation of
that exception is causing the exception to swallow the rulein a manner that is robbing
defendants of their Confrontation Clause rights. It should be stopped.
5. Repetitive Leading Questions
Defendants renew their objection to the Governments consistent habit of leading its
witnesses. This habit has extended well beyond the use of innocuous leading questions to
transition to a new topic. Instead, the Government repeatedly has used leading questions to
prompt its witnesses on matters of central importance to the trial. Further, even when the Court
has sustained defense counsels objections, the Governmentundeterredcontinues improperly
to lead its witnesses concerning the substantive content of their answers. The following
exchange is just one example of this recurring problem:
Q. And the explanation that you just gave about how it was designed and
how it worked, was that information that you received at Sinus Forum from the
A. That was the exact yes, that was most definitely how it was
Q. And do you recall any discussion or any recommendation that the
device be used as a postoperative spacer?
MR. PINEAULT: Objection, leading, Your Honor.
Q: What discussion was[] there[,] if any, about using the device as a
postoperative spacer?

A. Well, . . . it was very clearly stated that the expectation was that we
would not put saline in this.
MR. PINEAULT: Objection, Your Honor.
THE COURT: Thats sustained.
Q: Were you given any directions what directions if any were you given
with respect to the use of saline?
A. There were written directions to use saline on the printed marketing
Tr. 350:6-18 (emphasis added); see also, e.g., Tr. 4145:10-25 (after objection to question
[T]his shows it in commercial distribution as well, right? was sustained as leading, rephrasing
to What does this chart show about where the advanced drug delivery platform is, whether its
just in clinical or its in commercial?).
What was objectionable about the first question in each of the foregoing examples was
the Governments use of a leading question to prompt its witness concerning the specifics of
what the Government wanted the witness to say concerning the recommended use of Stratus (or
in the second example, the stage of Stratus). It does not correct the transgression for the
Government to repackage its question by asking what, if anything, was said about the use of
Stratus as a postoperative spacer (or to simply add an option for the stage of Stratus). Phrased
either way, the Government is impermissibly prompting its witness to cover statements regarding
the spacing function (or to state a particular stage) in his answer. 4
The jurors, of course, do not understand the rules of evidence. Instead, they see defense
counsel repeatedly standing up and interrupting the proceedings. Defendants should not be
placed in that position. The prosecutors are experienced attorneys who are capable of framing

See also, e.g., Tr. 5168:20-23 (And was he sending it around suggesting that it would
be a value to the sales representatives under your supervision?); Tr. 740:5-41:3 (Did you
understand that the FDA had not made a determination as to whether this device was proven safe
or effective when used to deliver Kenalog-40?)

non-leading questions. If, for whatever reason, they choose not to, Defendants request that the
Court admonish them with increasing sternness.
For the reasons stated above, as well as in their previously filed motions in limine and
previously asserted objections at trial, Defendants respectfully request that the Court issue
rulings that preclude the Government from engaging in the above-described conduct.

Respectfully submitted,



By: /s/ Michael J. Pineault

Clements & Pineault, LLP
24 Federal Street
Boston, MA 02110
Tel. (857) 445-0135

By: /s/ Frank A. Libby, Jr.

FRANK A. LIBBY, JR. (BBO No. 299110)
LibbyHoopes, P.C.
399 Boylston Street Suite 200
Boston, MA 02116
Tel. (617) 338-9300

LEO CUNNINGHAM (pro hac vice)

LISA A. DAVIS (pro hac vice)
Wilson Sonsini Goodrich & Rosati P.C.
650 Page Mill Road
Palo Alto, CA 94304
Tel. (650) 493-9300
REID H. WEINGARTEN (pro hac vice)
WILLIAM T. HASSLER (pro hac vice)
JESSICA L. URBAN (pro hac vice)
Steptoe & Johnson LLP
1330 Connecticut Avenue, NW
Washington, DC 20036
Tel. (202) 429-3000

Dated: June 20, 2016


I hereby certify that counsel for Defendants has previously conferred with counsel for the
United States concerning the evidentiary issues raised in this motion, pursuant to Local Rules 7.1
and 112.1.
/s/ Michael J. Pineault
Michael J. Pineault
I hereby certify that this document filed through the ECF system will be sent
electronically to the registered participants as identified on the Notice of Electronic Filing (NEF)
and paper copies will be sent to those indicated as non-participants on June 20, 2016.
/s/ Michael J. Pineault
Michael J. Pineault